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Clinical trial inspection welcome message

Clinical trial inspection welcome message, Total:67 items.

The international standard classification for "Clinical trial inspection welcome message" includes: Protection against crime , Medical Sciences and health care facilities in general , Dental materials .

The Chinese standard classification for "Clinical trial inspection welcome message" includes: Legal medical expert , Crime judging technology , Sanitation in general , Codification , Computer application , Stomatologic device, equipment and material .


Group Standards of the People's Republic of China

  • T/CAQI 366-2024 Clinical testing quantitative project method confirmation
  • T/QDAS 108-2023 Technical specification for mobile intelligent clinical examination platform
  • T/CVMA 65-2021 Technical specification for clinical urinalysis of canine and feline
  • T/CVMA 111.1-2023 Technical specification for physical examination of canine and feline——Part 1:Basic clinical examination of canine and feline
  • T/CQAP 3013-2023 Key points for quality inspection of clinical trial data management
  • T/SSFSIDC 015-2023 Clinical trial data collection requirements
  • T/CGCPU 008-2019 General Auditing Standards for Clinical Trials
  • T/SHSPS 002-2024 Standards for the management and competency evaluation of clinical trial monitors (Shanghai)
  • T/CGCPU 014-2020 The practices of chemicals for clinical trials in clinical trial institutions
  • T/SHDSGY 066-2023 Inspection service specification of clinical trial research center
  • T/SHAAV 001-2020 Clinical physical examination procedure for canine and feline clinic

司法部

  • SF/T 0111-2021 Specification of examination in forensic clinical medicine
  • SF/T 0112-2021 Implemental specification of clinical forensic imaging examination

Professional Standard - Certification and Accreditation

Professional Standard - Public Safety Standards

  • GA/T 1194-2014 Guideline for forensic clinical examination in sexual assault case
  • GA/T 1970-2021 Specifications for clinical forensic examination

卫生健康委员会

  • WS/T 804-2022 Basic technical standard for clinical chemistry laboratory
  • WS/T 662-2020 Technical requirements for clinical body fluids analysis
  • WS/T 641-2018 Internal quality control for quantitative measurement in clinical laboratory
  • WS/T 616-2018 Autoverification of Clinical Laboratory Quantitative Test Results
  • WS/T 644-2018 Clinical laboratory quality evaluation

Professional Standard - Hygiene

  • WS/T 255-2005 Clinical laboratory medicine-Requirements for reference measurement laboratories
  • WS 363.8-2011 Health data element dictionary—Part 8:Assistant examination
  • WS/T 102-1998 Classification and codes of clinical laboratory tests item
  • WS/T 402-2012 Define and determine the reference intervals in clinical laboratory

Jiangsu Provincial Standard of the People's Republic of China

  • DB32/T 4331-2022 Technical specification for clinical quantitative coronary flow fraction (QFR) examination

未注明发布机构

  • WS/T 514-2017 Establishment and verification of detection capability for clinical laboratory measurement procedures

中华人民共和国国家卫生和计划生育委员会

  • WS/T 227-2002 Requirement for the technical procedure manual in clinical laboratory
  • WS/T 124-1999 Inspection criteria of the quality of clinical chemistry in vitro diagnostic kits - General guideline
  • WS/T 228-2002 Preliminary evaluation of quantitative clinical laboratory methods

National Health Commission of the People's Republic of China

  • WS/T 805-2022 Basic technical standard for clinical microbiology laboratory

Professional Standard - Medicine

Professional Standard - Agriculture

  • CNAS-GL037-2019 Guidelines for performance verification of quantitative assay procedures in clinical chemistry

European Committee for Standardization (CEN)

  • EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
  • EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
  • EN ISO 14155-2:2003 Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans ISO 14155-2:2003

GSO

  • GSO ISO 14155:2015 Clinical investigation of medical devices for human subjects -- Good clinical practice
  • GSO ISO 3269:2008 Fasteners - Acceptance inspection
  • GSO ASTM F3108:2022 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
  • BH GSO ASTM F3108:2023 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery

British Standards Institution (BSI)

  • BS EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Clinical investigation plans
  • BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice

International Organization for Standardization (ISO)

  • ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants

Korean Agency for Technology and Standards (KATS)

  • KS P ISO 14155-2:2007 Clinical investigation of medical devices for human subjects-Part 2:Clinical investigation plans
  • KS B 6390-2011 Test code for performance and accuracy of jig grinding machines
  • KS B 4210-2002(2012) Teat code for performance and accuracy of bench drilling machines

RU-GOST R

  • GOST R 53133.3-2008 Medical laboratory technologies. Quality control of clinical laboratory tests. Description of materials for quality control of clinical laboratory investigations
  • GOST R 53022.3-2008 Clinical laboratory technologies. Requirements of quality of clinical laboratory tests. Part 3. Assessment of laboratory tests clinical significance
  • GOST R 52379-2005 Good clinical practice (GCP)
  • GOST R 53079.2-2008 Medical laboratory technologies. Quality assurance of clinical laboratory tests. Part 2. Guidelines for improvements of quality in clinical-diagnostic laboratory. Typical model

GOSTR

  • GOST R 58090-2018 Clinical examination of unproductive animals. General requirements

Japanese Industrial Standards Committee (JISC)

BE-NBN

  • NBN-EN 540-1993 Clinical investigation of medical devices for human subjects

GOST

  • GOST R ISO 14155-2-2008 Clinical investigation of medical devices for human subjects. Part 2. Clinical investigation plans
  • GOST ISO 2772-2023 Test conditions for box type vertical drilling machines. Testing of the accuracy

Association Francaise de Normalisation

  • NF ISO 3875:2020 Machine tools - Test conditions for centerless external surface grinding machines - Checking accuracy
  • NF ISO 8636-2:2008 Machine tools - Test conditions for gantry milling machines - Checking accuracy - Part 2: mobile gantry machines
  • NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice

American Society for Testing and Materials (ASTM)

  • ASTM F3108-19 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
  • ASTM F3448-20 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Hip Reconstructive Surgery

US-AAMI

IT-UNI

Danish Standards Foundation

  • DS/EN ISO 14155:2013 Clinical investigation of medical devices for human subjects - Good clinical practice